Perishable Pundit
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April 3, 2009 —
Perishable Pundit Overview:

SPECIAL EDITION — PISTACHIO RECALL HAS MORE QUESTIONS THAN ANSWERS

Pistachio Industry Effectively Shuts Down Because Of FDA Recommendation Not To Consume

Producer Contamination
Of Pistachios Is Rather Odd

Kraft At Crux Of Pistachio Recall;
Hasn’t Fully Audited Supplier
In Almost Four Years

Georgia Nut Company (Not The One Implicated In The Peanut Recall)Points Finger At Setton Pistachio

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The FDA has recommended that consumers not consume pistachios or pistachio-containing products. It also encouraged a recall by Setton Pistachio of over a million pounds of product, and the company elected to close its plant. (In true fashion of press briefings given in moments of crisis, there is a great discrepancy of how much of Setton’s total crop was affected, but the fact that the plant is now closed reveals total shut down of pistachios currently distributed by the company.)

Although FDA has not urged people to destroy the pistachios and pistachio-containing products — instead to simply wait until the derivation of the product is ascertained — much product will be destroyed. Supermarkets and others do not have excess freezer capacity to indefinitely store pistachio ice cream and there is no final date by which consumers will get an “all clear.”

FDA is proud of its role in this matter. Its Commissioner for Foods, Dr. David Acheson, proudly declared to reporters: “This recall was not triggered because of an outbreak, in contrast to the peanut butter. This is an example of the FDA getting out ahead of the curve.”

Actually, it is more an example of the FDA’s need to make itself relevant than anything to do with public health.

When people are advised not to eat a particular product, there is no reason to think that they eat less food; instead they eat less of the “banned” product and more of other foods. In order to be acting to enhance public health and safety, Dr. Acheson would have to have reason to believe that the food people will eat in lieu of these pistachios will be safer. Unfortunately he has no data to support such a belief.

This situation was uncovered because Kraft received word from its supplier, Georgia Nut Company, that in the course of its routine sampling of ingredients it purchases, had identified Salmonella on pistachios it had purchased from Setton Pistachio. Kraft decided, voluntarily, to notify the FDA.

Where this salmonella contamination may have occurred is unknown. In theory, the roasting of the pistachios should have killed any salmonella, so this points to either improper roasting or a contamination after they were roasted. Most plants are designed and operated utilizing Hazard Analysis And Critical Control Point (HACCP) principles. Because cross contamination between raw and roasted product is a known critical control point, most plants are designed as a “one way street” where raw product enters on one end of the plant, finished product leaves on the opposite end and product should never go backwards where it could come into contamination with raw product.

The Washington Post reported that it was told by a top food safety official that Setton Pistachio was running both raw and roasted nuts on the same line, which would violate both Good Manufacturing Practices and basic HACCP principles. The article also states that at some unidentified time, Setton Pistachiofound Salmonella on pistachios and, in accordance with accepted practice, reconditioned them by roasting them again.

None of this has been publically confirmed but, even if true, wouldn’t prove anything about where these four particular strains of Salmonella came in contact with the pistachios.

It is also possible that the problem was at the plant but in an episodic way that we may never find and could happen in any plant on any product — a freak, once-in-a-billion bunching of the pistachios just a micron too thick to kill the Salmonella through roasting — in which case the FDA’s actions have helped nobody because virtually all the pistachios do not have salmonella and these freak events happen across all foods, so we have no reason to think that a consumer who switches to, say, roasted peanuts, is any safer.

There are several oddities about the case. 1) We can find no reference to salmonella ever being discovered on pistachios — so this is not a high risk item. 2) The FDA said there were four different serotypes of salmonella discovered — Montevideo, Newport, Seftenberg, and Larochelle. This is peculiar. 3) So far no other tests — by the FDA, Setton Pistachio, Kraft, or any others have turned up any positives either in the nuts or in the plants. 4) The nuts were apparently sitting at the Georgia Nut Company facility for a long time, they were actually received in late 2008 — adding to the possibility that any contamination could have occurred during the months it has been sitting around the Georgia Nut Company facility.

If one wants lessons, industry certainly should get the message that it behooves the food trade to work hard on traceability. Whether FDA acts prudently or rashly, the ability to quickly define where all the potentially contaminated product is at any moment would significantly reduce the scope of the problem when panic is in the air. Industry also would do well to consider the use of technology, such as irradiation, to provide additional assurance.

But FDA has to recognize that it has a problem as well. Its procedure of reacting to test results done by private industry has the perverse effect of implicating and sometimes shutting down the most rigorous and highest quality producers. Why? The customers with the most rigorous requirements — like Kraft — buy from the best producers.

Yet it is in the nature of pathogens that if we tested every single piece of food, pathogens would be found in a certain percentage of the food — call this a baseline level. This is especially true of items such as raw produce but is also true of any food that isn’t kept sterile.

There is no requirement for private industry to test and no requirement to report test results to the FDA. Quite possibly because Setton Pistachio was good enough to sell to Georgia Nut Company, which is rigorous enough to have a regular testing program, and because the product was going to Kraft, which elected to be conscientious and report it to the FDA, the FDA was alerted to some salmonella which it would never have known about if Setton Pistachio was a second-rate operator selling to food manufacturers who wouldn’t bother to test and wouldn’t bother to report the test results if they got them.

So the FDA’s definition of “getting out ahead of the curve” really means getting out ahead of the news cycle so its executives can declare themselves guardians of the nation’s food supply. But responding to random events as if they have statistical significance makes nobody healthier and impoverishes those people who depend, in this case, on selling pistachio nuts.

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The decision to close an industry is a serious one. We wanted to learn as much as we could about the pistachio situation and so asked Pundit Investigator and Special Projects Editor Mira Slott to find out more.

People were pretty closed-mouthed, but Mira was able to clarify some important points:

Richard Matoian Executive Director Western Pistachio Association Fresno, California

Q: You say there are no current indications that pistachios processed outside of the Setton Pistachio facility are affected by this recall. How do you know this? Are you confident the problem is linked only to Setton Pistachio?

A: We’re going by what information was released by FDA, and from the press briefing. Government testing is being conducted right now from samples taken at the Setton facilities. Until we know those results, then and only then is there a confirmation to the source.

Q: What do you mean when you say, “…as a further precautionary measure, growers and processors are committed to continuing testing of pistachio shipments going forward” — as you mentioned in your statement. Are there additional food safety measures being done that are different than what was done before?

A: We do have good agricultural and manufacturing practices on the grower and processor side, adopted 15 years ago. On top of that, each and every processor is going through individual facility testing. We want to be doubly sure facilities are clean and safe, so they’re going through and doing additional testing. The last thing anything would want is to determine that the problem is larger.

Q: Are all pistachios roasted, providing a kill step?

A: For pistachios, even raw ones, they do go through a food safety process when brought in from the field. The outside hull is taken off and they go through a water bath that has chlorine in it. Lastly, a drying process removes moisture out of the nut to make it more shelf stable and also acts as a killing step, and the nuts are heated for four hours or so at 160 to 200 degrees.

Q: Is there any historical precedent for a problem like this to occur?

A: The industry believes this is an isolated incident. We never had salmonella found on pistachios before.

Q: Never?

A: In our industry, we never had a problem with salmonella contamination. Everyone was perplexed when they heard Kraft reported to FDA the finding of salmonella on pistachios.

We appreciate Mr. Matoian’s taking the time to help clarify this issue for the industry. It would be helpful if he could be more definitive about the “kill step” — this is typically expressed as a “log reduction,” which is a 10-fold, or 1 decimal place or 90% reduction in a pathogen. Here is an FDA log-reduction chart:

And FDA gives this simple example:

Two Practical Ways of Looking at 5-Log Reduction:

Reduction of 100,000 bad bugs in one contaminated serving to 1 bad bug in a serving.

Reduction of 100,000 contaminated servings to 1 contaminated serving.

All associations or organizations that claim they have some sort of “kill step” need to express the efficacy of such steps in this sort of language if they are to be persuasive to the media and thus the public. Some food safety experts have told us you need heat of at least 300 degrees F. to kill Salmonella.

Still, we have a product not known to harbor salmonella and that has some sort of kill step. To leap to the conclusion from an isolated finding on pistachios that have been sitting in a customer’s facility for months that this establishes even a prima facie case for producer-contamination is rather odd.

Once again, thanks to Richard Matoian and the Western Pistachio Association for helping to explain the intricate world of pistachios to the broader industry.

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Kraft occupies an odd position in this pistachio matter. It didn’t grow or process the pistachios; it didn’t even receive them or, initially, test them. Yet its policies on food safety and contacting government agencies have really been the catalyst for the whole matter.

We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Adrienne Dimopoulos Senior Manager, Corporate Affairs Operations, Kraft Foods Northfield, Illinois

Q: How did Kraft identify the source of the contamination to be pistachios from Setton Pistachio?

A: During the testing of ingredients, the external manufacturer, Georgia Nut Company, discovered there was a small potential for Salmonella in a batch of pistachios supplied by Setton. Georgia Nut informed us that a spot test revealed Salmonella. They notified Kraft and together we contacted FDA.

We’re proud of the comprehensive programs we have in place. Our quality control systems were effective in this instance.

Q: Did Kraft conduct its own independent testing to confirm these results?

A: We dispatched our own auditors out to Setton Pistachio. They were there for several days.

Q: What did Kraft learn during the audit?

A: We did our own observations and testing at Setton facilities… lots of environmental testing, ingredient and product testing. Auditors went over the entire facility to be sure food safety systems were in place. Kraft did a comprehensive audit.

Q: Did Kraft find Salmonella contamination in its testing at the Setton plant? Were you able to link the four Salmonella serotypes found during the Georgia Nut testing to the Setton facilities?

A: Georgia Nut Company discovered the Salmonella. I’m not sure what Kraft’s test results revealed. In their testing, Georgia Nut found Salmonella, called Kraft and then reached out to Setton, the supplier.

In my understanding of how product testing for pathogens works, you could have a whole batch of nuts and one little spot test comes back positive for Salmonella and the rest of the batch could be fine.

Q: How does Kraft know definitively that the contamination occurred at the Setton plant and not some time after it left the facility?

A: At Setton Pistachio, our auditors observed situations where raw and roasted pistachios were not properly segregated. This could explain the sporadic contamination. We saw raw and roasted product processed on the same line without proper sanitation in between the raw and the roasted products. It wasn’t up to what we would want them to do.

Then the FDA did their own investigation and also determined potential risk for contamination.

Q: If March was the first time samples from Setton product came back positive for Salmonella, why are products from months earlier being recalled? And why is FDA telling consumers not to eat any pistachios period?

A: Setton Pistachio is not the only supplier out there, and not every code date is affected. We wanted to move as quickly as possible to remove any potentially contaminated product from store shelves. We didn’t want to take any risks.

Q: Does Kraft conduct routine audits of its suppliers? Why wasn’t Setton Pistachio operating up to Kraft’s food safety standards?

A: We regularly do audits and conduct testing. We do audit our manufacturers and their suppliers. We share with them what processes we would like them to implement in their plants.

Q: So to clarify, Kraft did do audits of the Setton plant before this most recent visit?

A: We conducted a full audit of the Setton plant in December 2005, and visited the plant in December 2008 for a technical audit.

It’s important to know an inspection is a one-point-in-time event. What becomes critical is consistent food safety processes in place during the manufacturing at all times.

Audits do not guarantee food safety. What makes it safer is larger protocols in place and comprehensive checks to insure the food safety system is working. We’ll be evaluating frequency of audits.

We have an audit program to verify compliance. We require an external manufacturer to have a food safety plan in place; none is perfect, but when we have a situation like this we review it and learn how we can do it better.

Q: Did Setton Pistachio supply raw or roasted product to Georgia Nut Company? In what form did it arrive?

A: Setton supplied bulk roasted shelled pistachios processed and ready to go into products Georgia Nut Company manufactures.

Q: Is Kraft working with Setton Pistachio to address the problems?

A: Setton Pistachio is very committed to resolving this, and is a very solidly managed company. They’re not by any means trying to shirk any of their role in this. They want to get this right.

There is always a temptation to clam up at a time like this. So we appreciate very much that Adrienne Dimopoulos and Kraft Foods are trying to provide some needed transparency in this very murky subject. We note eight key points from the discussion:

1) “We’re proud of the comprehensive programs we have in place. Our quality control systems were effective in this instance.”

Actually we are not really sure about that. So a test found one little spot of
Salmonella — does that show a testing program is effective or that it just got “lucky” and hit a spot. Presumably if we tested every pistachio nut every day, we would find pathogens every now and then — maybe every hour. Is the testing program frequent enough to be statistically valid? If not, is “effective” the right word for such a chance discovery?

2) “I’m not sure what Kraft’s test results revealed.”

If Kraft’s tests had shown positive results, it would have told the FDA, which would have included that in its statement. It is a safe bet that, so far, at least, no other confirmations have been found.

3) “In my understanding of how product testing for pathogens works, you could have a whole batch of nuts and one little spot test comes back positive for Salmonella and the rest of the batch could be fine.”

We did a very thorough interview with Dr. Mansour Samadpour, an advocate for finished product testing. Much of it went to discussion of whether the testing was being done enough to be statistically meaningful. If, as Ms. Dimopoulos explains, one tiny spot on one pistachio could be positive while the thousands of pistachios surrounding that one are fine, how is it plausible that anyone is doing enough testing to get meaningful results? And if the results are not meaningful, isn’t shutting down an industry a ridiculous overreaction?

4) “At Setton Pistachio, our auditors observed situations where raw and roasted pistachios were not properly segregated. This could explain the sporadic contamination. We saw raw and roasted product processed on the same line without proper sanitation in between the raw and the roasted products. It wasn’t up to what we would want them to do.

Then the FDA did their own investigation and also determined potential risk for contamination.”

This is a little unfair. Finding a plausible route for contamination is neither proof nor evidence that the contamination occurred that way. Perhaps it “could explain” something but it doesn’t preclude alternative explanations.

5) “Setton Pistachio is not the only supplier out there, and not every code date is affected. We wanted to move as quickly as possible to remove any potentially contaminated product from store shelves. We didn’t want to take any risks.”

Kraft is not responsible for the decisions of the FDA. But the FDA did not simply choose to pressure this one supplier for a recall; it decided to issue a recommendation not to consume. It intentionally did not choose to exonerate states such as Arizona and New Mexico — as it did with tomatoes in the Salmonella Saintpaul outbreak this summer.

It also didn’t distinguish between processed products, where consumers might have trouble identifying the source of the pistachios, and jars or bags of pistachios that are easy to identify.

Finally it is treating a finding by one producer as statistically meaningful, when it is not.

We also question the FDA’s reliance on a private company in this matter. Who is to say that a private citizen with a grudge couldn’t one day implicate a person or company with the goal of ruining the company or a whole industry?

6) “We conducted a full audit of the Setton plant in December 2005, and visited the plant in December 2008 for a technical audit.”

Gadzooks! 2005 for the last full audit?? Even the companies that have great reputations for food safety, such as Kraft, really don’t do the job. Three-plus years is an eternity in the life of a factory.

7) “It’s important to know an inspection is a one-point-in-time event. What becomes critical is consistent food safety processes in place during the manufacturing at all times.

Audits do not guarantee food safety. What makes it safer is larger protocols in place and comprehensive checks to insure the food safety system is working. We’ll be evaluating frequency of audits.”

Bottom line: If one wants “consistent food safety processes in place during…all times” and “larger protocols in place and comprehensive checks,” one probably needs a comprehensive audit more frequently than every three years — and who knows when Kraft would have come back were it not for this situation.

We thank Adrienne Dimopoulos and Kraft Foods for helping the trade to understand better what really has happened in this pistachio situation.

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Joshua Robbins Spokesperson Georgia Nut Company Skokie, Illinois

Q: In its recall release, Georgia Nut Company said it identified the Salmonella as a result of “a rigorous sampling and testing regimen it conducted with respect to shelled pistachios provided by [Setton].” What is your testing protocol? Was this rigorous testing typical and part of a routine, continuous testing program, or was it ratcheted up because of the peanut butter crisis perhaps? Do you do a test-and-hold program?

A: What led to this discovery and the subsequent recall was a result of our regular testing program in place and this fit into that. We don’t share details of our company’s internal testing and operating procedures.

Q: How do you know for sure that the problem originated at Setton and not some time after it left the plant? It did seem notable that the testing showed four different strains of Salmonella…

A: I can’t speak to the technical, scientific side of that testing. We traced it back to the supplier, and are confident it is not an environmental problem in our facility. All our environmentals tested clean.

Q: If you do a continuous testing program, and March 2009 was the first time Setton product tested positive for Salmonella, why are products being recalled going back to September 1, 2008? Setton reported that the product you recently tested with the positive results was actually received by Georgia Nut Company in late 2008. Is that right?

A: When dealing with lot numbers and getting into the amount of product shipped, I’m not an expert at that. As soon as things were discovered, we alerted the supplier and we worked with FDA. That was on Monday, March 23, and our recall went out on March 25.

Q: You certainly showed resolve and expediency in addressing the problem once you discovered it.

A: We’re a small family company and have never dealt with a recall like this in 60 years of business. We’re not used to hundreds of people wanting to know everything about our business. We’re focused on producing quality product and taking care of our customers. We’re fielding calls because we were the first out there. Were trying to manage the situation the best we can.

We have a regular testing program in place, and we were able to locate the source. Our specific recall for Georgia Nut Company was relatively small. None the less, this is a big challenge for us to handle.

A lot of people thought we were the infamous Georgia company from the peanut butter crisis. Of course, Georgia Nut Company is based in Skokie, Illinois, and the Georgia in our company is not a state, but the name of a woman. Once all the attention dies down, there’s a possibility we’ll have more we can share with you.

Yes it can be overwhelming for a small family-owned business to suddenly find itself in the public eye. That is why crisis management is so important.

But there is no reason a company should be reticent to discuss its food safety program. It should be so proud of its program and want to discuss every detail.

We appreciate the time that Joshua Robbins and the Georgia Nut Company took to speak with us, but we are not certain that the logic of the argument being made holds. Mr. Robbins says that the company knows that the pistachios couldn’t get contaminated at its facility. How does he know this? Well he explains that “All our environmentals tested clean.”

Yet the failure to find something doesn’t prove anything at all. And, so far at least, nobody has found any place where the “environment” is filled with these strains of Salmonella — including, so far, no such finding at Setton Pistachio.

The fact that these pistachios were sitting at the Georgia Nut Company for months raises real questions about where the contamination may have occurred. So far nobody has provided a compelling explanation for how it was a problem back at Setton Pistachio.

Hopefully Mr. Robbins will be able to tell us more soon. Many thanks to him and to Georgia Nut Company for helping to explain this matter to the industry.